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Combination Chemotherapy and Trastuzumab in Treating Women With Stage I, Stage II, or Stage III HER2-Positive Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00629278
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : March 5, 2008
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known which regimen of combination chemotherapy given together with trastuzumab is most effective in treating breast cancer.

PURPOSE: This randomized phase III trial is comparing two different regimens of combination chemotherapy given together with trastuzumab to see how well they work in treating women with HER2-positive stage I, stage II, or stage III breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: trastuzumab Drug: aromatase inhibition therapy Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride Drug: epirubicin hydrochloride Drug: fluorouracil Drug: paclitaxel Drug: releasing hormone agonist therapy Drug: tamoxifen citrate Procedure: adjuvant therapy Radiation: radiation therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : December 2007
Estimated Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Primary Outcome Measures :
  1. Disease-free survival
  2. Overall survival

Secondary Outcome Measures :
  1. Failure rate at 2 years due to relapse, death, or toxicity
  2. Incidence of cardiac events as assessed by NCI CTCAE V3.0

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Diagnosis of infiltrating primary breast cancer

    • Stage I-IIIA disease
    • Resected tumor with free margins (i.e., no neoplastic cells on the resected margin)

      • Must have node-negative sentinel node or complete axillary clearance

        • Axillary clearance required for micrometastasis (between 0.2 and 2 mm) in the sentinel node but not for isolated tumor cells
      • Treatment is scheduled to begin within 10 weeks from the date of surgery

        • Date of the last surgery will be taken into account for patients undergoing re-excision of positive margins or axillary lymph node dissection after positive sentinel node biopsy
  • Node positivity or node negativity AND ≥ 1 of the following:

    • T > 2 cm
    • Grade 3
    • Presence of lymphovascular invasion
    • Ki 67 > 20%
    • Age 35 years
    • Hormone receptor negativity (<10%)
  • HER2-positive tumor (3+ by IHC or FISH+ according to the American Society of Clinical Oncology guidelines [i.e., > 2.2; in case of polysomy, with ≥ 6 gene copies])
  • Estrogen receptor-positive and/or progesterone receptor-positive disease


  • Female
  • Pre- or postmenopausal status

    • Postmenopausal status defined by ≥ 1 of the following:

      • At least 60 years of age
      • Less than 60 years of age and amenorrheic for ≥ 12 months prior to day 1
      • Less than 60 years of age and amenorrheic for < 12 months prior to day 1 with luteinizing hormone and follicle-stimulating hormone values within postmenopausal range OR without a uterus
      • Prior bilateral oophorectomy
      • Prior radiation castration with amenorrhea for ≥ 6 months
  • ECOG performance status 0-1
  • Suitable for adjuvant chemotherapy
  • WBC > 3,000/mcL
  • ANC > 1,500/mcL
  • Platelet count >100,000/mcL
  • Total bilirubin normal
  • AST and ALT 2.5 times upper limit of normal
  • Creatinine normal
  • Cardiac ejection fraction normal as measured by ECHO or MUGA scan
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study therapy
  • No contraindication to anthracycline, cyclophosphamide, fluorouracil, paclitaxel, or trastuzumab (Herceptin®) treatment
  • No uncontrolled intercurrent illness including, but not limited to, the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness/social situations that would limit compliance with study requirements


  • See Disease Characteristics
  • See Patient Characteristics
  • No prior chemotherapy, endocrine therapy, or radiotherapy
  • No other concurrent investigational agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00629278

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Ospedale Santa Croce Recruiting
Cuneo, Italy, 12100
Contact: Contact Person    39-0171-441-309      
Ospedale Civile di Ivrea Recruiting
Ivrea, Italy, 10015
Contact: Contact Person    39-0125-4141      
Azienda Ospedaliera - Universitaria di Modena Recruiting
Modena, Italy, 41100
Contact: Pier Franco Conte, MD    39-059-422-4538   
Piacenza Hospital Recruiting
Piacenza, Italy, 29100
Contact: Contact Person    39-052-330-3123      
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino Recruiting
Turin, Italy, 10126
Contact: Contact Person    39-011-633-1633      
Ospedal San Andrea Recruiting
Vercelli, Italy, 13100
Contact: Contact Person    39-161-593-418      
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria di Modena
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Principal Investigator: Pier Franco Conte, MD Azienda Ospedaliero-Universitaria di Modena
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00629278    
CDR0000584446 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: July 2009
Keywords provided by National Cancer Institute (NCI):
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
HER2-positive breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Aromatase Inhibitors
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors